Tsuei S E, Darragh A S, Brick I
J Antimicrob Chemother. 1984 Sep;14 Suppl C:71-4. doi: 10.1093/jac/14.suppl_c.71.
Twenty-four subjects participated in this placebo-controlled, double-blind study. Eighteen were randomized to receive active enoxacin capsules (400 mg twice daily for 14 days) and the remaining six received placebo therapy. Steady state was reached in four days or less, with an average minimum concentration of 1.25 mg/l and the average concentration achieved 1.5 h after the dose was 3.53 mg/l. Five of 18 (28%) subjects who received active enoxacin and two of six (33%) subjects who received placebo reported adverse events, which were generally mild and of short duration. No rash or pruritus were reported. Haematology, biochemistry and urinalyses revealed no untoward effect.
24名受试者参与了这项安慰剂对照双盲研究。18名受试者被随机分配接受活性依诺沙星胶囊(每日两次,每次400毫克,共14天),其余6名接受安慰剂治疗。4天或更短时间内达到稳态,平均最低浓度为1.25毫克/升,给药后1.5小时的平均浓度为3.53毫克/升。接受活性依诺沙星的18名受试者中有5名(28%)和接受安慰剂的6名受试者中有2名(33%)报告了不良事件,这些事件通常较轻且持续时间较短。未报告皮疹或瘙痒。血液学、生物化学和尿液分析未显示出不良影响。